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eRAD RIS

FDA UDI

Class II (US FDA UDI)

by Erad, Inc.

Identity

Trade Name
eRAD RIS FDA UDI
Generic Name
Radiology information system application software FDA UDI
Device Name
eRAD RIS v2.2016 FDA UDI
Model / Reference
2.16 FDA UDI
Description
eRAD RIS v2.2016 FDA UDI

Identifiers

Primary DI / UDI-DI
00866994000231 FDA UDI
510(k) Number
K120995 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology information system application software

eRAD RIS by Erad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology information system application software.

Cleared under the same submission

K120995 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Erad, Inc.

Sources (1)

  • FDA UDI 2396b146-2844-43b6-ac78-7389b5724f95 35 fields · synced May 31, 2026